Feliza Mirasol

Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.

Dan Williams, PhD, SynaptixBio CEO, discusses how rare disease drug development leverages genetic targeting and drives innovation and investment in pharmaceutical technology and precision medicine.

The Hopewell, N.J., site adds scalable, end-to-end viral vector production with integrated quality systems to speed clinical and commercial gene therapy programs.

Strand advances targeted mRNA therapies, with Phase I STX-001 solid tumor data presented at the 2025 ASCO Annual Meeting.

The newly launched facility is located in The Woodlands, Texas, and will produce plasmid DNA as well as strengthen biopharma supply chains.

The additional approval expands the label for Avtozma (tocilizumab-anoh) to now include the treatment of cytokine release syndrome, which aligns the therapy with all indications for which Actemra is approved in the US.

The acquisitions include three testing laboratories that enhance Normec’s ability to serve key highly regulated sectors in the TICC industry.

Avantor's Jerry Keybl, senior vice-president, Biopharma Products and Strategy, highlights innovations in biomanufacturing and recalls his impressions of INTERPHEX 2025, held this past April.

Bristol Myers Squibb is seeking approval of Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory marginal zone lymphoma, making this the fifth cancer type for which the cell therapy would be approved.

Under the licensing agreement, the proposed biosimilar candidate, PolyPB016, will be developed and manufactured by Polpharma Biologics and commercialized by Fresenius Kabi.

Phase III study findings emphasize donanemab-azbt's (brand name Kisunla) ability to slow the decline of patients exhibiting early symptomatic Alzheimer’s disease.

At AAIC 2025, Roche presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios.

The new spinning plant to be built in Nobeoka City, Miyazaki, Japan will produce hollow-fiber cellulose membranes, expanding production of the virus removal filters.

As more originator biologics lose patent exclusivity in the next decade, a healthy biosimilars pipeline is necessary but requires market support.

Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.

The biopharmaceutical landscape is undergoing a huge shift from traditional therapies to more specialty-driven modalities.

Through the collaboration, Pharmaron will validate and promote the application of CN Bio’s PhysioMimix technology with plans to integrate OOC technologies into its R&D platform.

AnalytiChem has launched the Redipor line of ready-to-use culture media, which brings three well-known brands under one global brand.

Avidicure is a new biotechnology company that has been launched on the back of a $50 million seed financing round for developing a new multifunctional antibody modality for treating cancer.

The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.

Using cholesterol-modified oligonucleotides, the research team aims to improve the delivery of antisense nucleotide-based therapies for treating neurodegenerative diseases and brain cancers.

This collaboration aims to advance a first-in-human clinical study by using autologous iPSC technology.

Celltrion’s adalimumab-aaty is designated interchangeable as a high-concentration (100mg/mL) and citrate-free formulation of adalimumab.

Eculizumab-aagh (EPYSQLI) is now available in the US to treat patients living with difficult-to-treat rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.

The spray-dried formulations for Ethris’ mRNA vaccine candidates will be developed at Lonza’s Bend, Ore., Center of Excellence in accordance with GMP standards.

Through this collaboration, Circio will combine its circVec DNA vectors with Entos’ Fusogenix PLV delivery technology, which is expected to enhance delivery efficiency and reduce toxicity.

The acquisition of Rweality will strengthen Enosium Life Science’s market access and medical-economic development strategies.

The EMA has issued a new proposal that aims to encourage biosimilar development and improve patient access to biosimilar therapies.

Rising demand for peptide-based therapeutics prompts the launch of this new peptide research center, which will offer services across peptide synthesis, discovery, and advanced modalities.

Wider adoption of single-use technologies and systems is aligning with sustainability goals for the industry.